Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ferno · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

161 daysmedian FDA review time
246 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932260FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATEFerno1993-09-091420
K931346FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-ITFerno1993-08-251610
K924669FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-WFerno1993-04-292250
K924023FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917Ferno1993-04-142460
K914125FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403Ferno1991-10-25420

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda